The Central Drugs Standard Control Organization (CDSCO) has issued a circular for ease of business in its initiative of regulating class C & D medical devices. This circular was issued on May 16, 2024.
It may be recalled that the Ministry of Health & Family Welfare (MoHFW) had published a notification dated February 11, 2020 bringing all medical devices under the ambit of the Drugs and Cosmetics Act, 1940. This notification was effective from April 1, 2020.
Additionally, by a notification also dated February 11, 2020, the MoHFW notified that all Class C & D medical devices would require a license for import and manufacture, starting October 1, 2023.
However, the CDSCO has received concerns from industry stakeholders regarding potential disruptions due to the new licensing requirement.
In light of these concerns the CDSCO has decided that existing importers and manufacturers of Class C & D medical devices who submitted license applications to the Central Licensing Authority (CLA) by September 30, 2023, can continue their operations till August 16, 2024.
These companies can continue importing or manufacturing their devices:
- Up to August 16, 2024 or
- Until a decision is made on their license application by the CLA, whichever comes sooner.
This grace period aims to minimize disruptions for companies that have already initiated the licensing process.
